Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
Under the partnership, Bharat Biotech will use the patented virus like particle technology platform of Novavax to develop the single dosage pandemic influenza vaccine and undertake clinical trials before manufacturing and marketing the same.\n\n
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
'iNCOVACC' is priced at Rs 800 for private markets and at Rs 325 for supplies to the government of India and state governments.
First a scientist and then a businessman, founder chairman Krishna Ella quit his faculty position at the Medical University of South Carolina in Charleston, United States, in 1996 to return to India.
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
iNCOVACC is the world's first intranasal vaccine for COVID-19 to receive approval for the primary two-dose schedule, and as a heterologous booster dose.
Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for emergency use listing during July-September.
The company said it had conducted two separate trials for its intranasal Covid vaccine, one as a primary dose schedule and another as a booster dose, for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India.
The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
Bharat Biotech said that it is disheartening to listen to some states complaining about company's intentions regarding supply of COVID vaccine Covaxin.
'He came back from the US only to work for his country.' 'He has invested his fortunes to build this company and is married to his work.' 'Rarely does one see such commitment.'
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
The Hyderabad-based manufacturer uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
After reports claimed that filings in patent offices in India, the US, and Europe did not mention ICMR or its scientists, but only BBIL and its scientists, the Hyderabad-based biotechnology (biotech) company clarified that in the "rush" to develop vaccines and file appropriate patents, BBIL had missed adding ICMR's name in the original filings.
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said
Bharat Biotech on Thursday said it plans to produce additional 200 million doses of COVID-19 vaccine 'Covaxin' at its subsidiary's Ankleshwar (Gujarat) based facility, taking the overall production volume of the vaccine to 1 billion (100 crore) dosages per annum.
This follows a widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose.
The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results.
Bharat Biotech started work on developing a vaccine against Zika way back in 2014.
'Our problem is not a budget deficit but a trust deficit. We need to trust our institutions and industries to innovate and lead. That is the way forward for India.'
WHO has urged people at risk to keep up with their vaccinations with boosters.
The Brazilian health regulator's decision comes after the vaccine maker informed the South American country about the termination of its pact with its partners in that country.
Karnataka Chief Minister Siddaramaiah alleged that the rushed approval and distribution of the COVID-19 vaccine may be a contributing factor to cardiac arrest deaths, citing several international studies that recently suggested a possible link between the vaccines and a rise in heart attacks.
Bharat Biotech recruited 13,000 participants for the Phase-3 clinical trial of Covaxin. This is one of the largest efficacy trials held in the country.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
Microsoft Chairman and CEO Satya Nadella along with Alphabet Inc and its subsidiary Google CEO Sundararajan Pichai are also among those from trade and industry who have been awarded the Padma Bhushan for their distinguished services.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
Simplifying investment policies at the micro level and introducing a time-bound framework will be critical for India's growth targets, notes Krishna Ella.
The BJP received the highest amount in large donations among national parties in the financial year 2023-24, with over Rs 2,243 crore declared from 8,358 donations, according to a report by poll rights body the Association for Democratic Reforms (ADR). The report, based on data submitted to the Election Commission, highlighted trends in political donations above Rs 20,000. The total declared donations to national parties stood at Rs 2,544.28 crore from 12,547 contributions - a sharp 199 per cent increase compared to the previous year.
"The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the consent form said.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
Reacting to it, the vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
Homegrown vaccine maker Bharat Biotech will launch its intranasal COVID-19 vaccine iNCOVACC, the first of its kind in India, on January 26, the company's chairman and managing director Krishna Ella said in Bhopal on Saturday.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
'If you align your ambition with India's rise, the peak of your careers will unfold alongside the peak of India's power.'
India is emerging as a major hub for global clinical trials and this new sector is poised to generate more revenue than the information technology industry by 2010, an industry leader has forecast.
Safety and Efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication.
This is the amazing story of Dr Krishna M Ella, a scientist who turned into a serial entrepreneur.
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